Henry Schein - Acclean Gentle Pick - HENRY SCHEIN, INC.

Duns Number:012430880

Device Description: Acclean Gentle Pick

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More Product Details

Catalog Number

5701409

Brand Name

Henry Schein

Version/Model Number

5701409

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JET

Product Code Name

PICK, MASSAGING

Device Record Status

Public Device Record Key

f21d48c2-80a3-4362-9f99-1dc0f92236c9

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 07, 2019

Additional Identifiers

Package DI Number

20304040108912

Quantity per Package

12

Contains DI Package

10304040108915

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"HENRY SCHEIN, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3829
2 A medical device with a moderate to high risk that requires special controls. 2579
3 A medical device with high risk that requires premarket approval 1
U Unclassified 34